CSV Execution Lead: Automation Validation Expert
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Benefits offered by this job
Job summary
Johnson & Johnson in Leiden, Netherlands, is recruiting for Computerized System Validation (CSV) Execution Lead within Innovative Medicine. This 12-month contract with potential conversion to permanent; you will lead validation activities across automation, digital, and GMP-relevant systems on capital projects and daily operations.
You will coordinate with Engineering, Quality, Manufacturing, IT, and project teams, mentor validation engineers, and ensure systems meet company standards and
Qualifications
- Bachelor's or Master's degree in Engineering, Automation, CS, IT, Life Sciences, or related field.
- 5+ years in GMP-regulated pharma/biotech/medical device with CSV experience.
- Knowledge of cGMP, GAMP 5, DI, ALCOA+, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with qualification/validation docs: URS, protocols, reports, traceability, deviations, CAPAs, change controls.
- Fluent written and spoken English.
Responsibilities
- Lead CSV and qualification across full system lifecycle.
- Define risk-based validation strategies per GAMP 5.
- Integrate Data Integrity standards into CSV workflows.
- Support lifecycle governance for automation systems.
- Lead change impact assessments, deviation investigations, and CAPAs.
- Maintain inspection-ready validation documentation and act as contact for inspections.
- Manage CSV scope, estimates, resources, and maintain the CSV work catalogue.
- Coach validation engineers and coordinate cross-functional teams.
Skills
Education
Tools
Job description
Johnson & Johnson in Leiden, Netherlands, is recruiting for Computerized System Validation (CSV) Execution Lead within Innovative Medicine. This 12-month contract with potential conversion to permanent; you will lead validation activities across automation, digital, and GMP-relevant systems on capital projects and daily operations.
You will coordinate with Engineering, Quality, Manufacturing, IT, and project teams, mentor validation engineers, and ensure systems meet company standards and
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